Is remdesivir safe for pregnancy? An Updated Look at Treatment for Expectant Mothers

October 10, 2025 •

4 min read

Pregnant individuals are at a higher risk of developing severe complications from COVID-19 compared to their non-pregnant counterparts. The question of is remdesivir safe for pregnancy? has evolved as more data has become available from compassionate use programs, registries, and observational studies, providing better guidance for clinicians and expectant mothers.

Quick Summary

Limited data from clinical trials initially raised concerns about remdesivir, but extensive post-marketing surveillance and studies offer reassurance. Benefits of treating COVID-19 in pregnancy often outweigh theoretical risks, and pharmacokinetic data suggest similar drug levels to non-pregnant individuals. This supports its use in moderate-to-severe cases under clinical guidance, with monitoring for potential adverse events like elevated liver enzymes.

Key Points

Limited Initial Data: Initial clinical trials for remdesivir excluded pregnant individuals, leading to a knowledge gap early in the pandemic.
Reassuring Pharmacokinetics: Recent studies have found that remdesivir plasma levels are similar in pregnant and non-pregnant individuals, indicating no need for dose adjustments.
Positive Maternal Outcomes: Observational data suggests remdesivir can reduce hospital stays and oxygen requirements for pregnant patients with moderate-to-severe COVID-19.
Low Fetal Risk Observed: While the metabolite can cross the placenta in animals, human data from registries and compassionate use programs have not identified a drug-related risk of adverse pregnancy outcomes or birth defects.
Breastfeeding is Generally Safe: Remdesivir and its metabolite pass into breast milk in very low, poorly absorbed amounts, making it generally compatible with breastfeeding while monitoring the infant.
Monitoring for Adverse Events: Providers should monitor for potential side effects such as elevated liver enzymes (transaminitis), a known adverse reaction to remdesivir.

The Evolving Picture of Remdesivir in Pregnancy

Initially, clinical trials for remdesivir (marketed as Veklury®), an antiviral medication developed for COVID-19 and Ebola, excluded pregnant and breastfeeding individuals, leaving a gap in understanding its safety and efficacy in this vulnerable population. As the COVID-19 pandemic progressed, observational data from compassionate use programs and drug registries became the primary sources of information. This growing body of evidence has since provided clearer insights, with current recommendations now including remdesivir for pregnant individuals who meet specific clinical criteria for moderate-to-severe COVID-19.

Pharmacokinetics: Drug Levels in Pregnant vs. Non-Pregnant Individuals

One critical area of research focuses on pharmacokinetics, which examines how a drug is absorbed, distributed, metabolized, and eliminated by the body. A 2024 study investigated the pharmacokinetics and safety of remdesivir in hospitalized pregnant and non-pregnant individuals.

Comparable Drug Levels: Researchers found that plasma levels of remdesivir and its major metabolites were similar between the two groups.
No Dose Adjustment Needed: The similar drug levels suggest that dose adjustments are not necessary for pregnant patients when receiving intravenous remdesivir.

While the drug itself may have low transplacental transfer, a metabolite called GS-441524 has been shown to cross the placenta in rat models. This highlights the need for continued monitoring and research, but the overall human data has been reassuring so far.

Impact on Maternal Health

COVID-19 infection during pregnancy carries its own significant risks, including higher chances of severe symptoms, intensive care unit (ICU) admission, and need for mechanical ventilation. For pregnant individuals with moderate to severe COVID-19, remdesivir has demonstrated potential benefits in improving clinical outcomes. Retrospective cohort studies have shown:

Reduced Hospital Stay: In a study of pregnant patients with moderate-to-severe COVID-19, remdesivir was associated with a significantly shorter length of hospital stay.
Decreased Oxygen Requirements: Remdesivir treatment was linked to a reduced need for oxygen support in patients initially on low-flow oxygen.
Lower Risk of Severe Complications: One study noted a lower percentage of patients in the remdesivir group developing preeclampsia compared to the non-remdesivir group.

However, it is crucial to remember that some adverse events have been reported. A toxicosurveillance project identified elevated serum alanine aminotransferase (ALT), a marker of liver function, as a common adverse event in pregnant patients receiving COVID-19 therapeutics, including remdesivir. While some patients required discontinuation of treatment due to high ALT levels, liver failure was not observed.

Fetal and Neonatal Outcomes

Data on fetal and neonatal outcomes is also being carefully collected. Although some small studies have suggested a higher incidence of preterm delivery and low birth weight in very sick, remdesivir-treated pregnant women, it is difficult to separate the effects of the medication from the severe COVID-19 infection itself. A positive finding from studies using remdesivir in pregnant patients is the absence of any reports of adverse pregnancy outcomes, congenital anomalies, or maternal deaths related to the treatment. Neonatal side effects have also been rare.

Is Remdesivir Safe While Breastfeeding?

Available evidence suggests that breastfeeding can continue during remdesivir treatment. Data from five patients showed very low levels of remdesivir and its active metabolite in breast milk. The drug is also poorly absorbed orally, meaning infants are unlikely to absorb clinically significant amounts. For example, one case report detailed a patient who resumed breastfeeding without adverse effects on her infant.

Low Oral Absorption: Infants do not absorb remdesivir effectively from breast milk.
Safety Profile: Remdesivir has been approved for infants older than 28 days for COVID-19, and no serious adverse reactions have been reported in infants exposed via breast milk.
Monitoring is Key: Despite reassuring data, healthcare providers recommend careful monitoring of the infant while the mother is being treated.

Remdesivir vs. Other COVID-19 Treatments in Pregnancy

Choosing the right antiviral treatment for COVID-19 in pregnancy requires a careful balance of risks and benefits. Here is a comparison of remdesivir with other common therapies:


Feature	Remdesivir (Veklury®)	Nirmatrelvir/Ritonavir (Paxlovid)	Molnupiravir (Lagevrio®)
Route of Administration	Intravenous infusion	Oral tablets	Oral capsules
Pregnancy Risk Summary	Limited first-trimester data, but reassuring evidence in later trimesters and post-marketing.	Limited human data on nirmatrelvir, but reassuring data for ritonavir.	Use generally not recommended unless benefits outweigh risks due to embryo/fetotoxicity in animal studies.
Available Evidence (Pregnancy)	Growing body of observational data and pharmacokinetic studies suggest comparable drug levels to non-pregnant patients.	Human data on nirmatrelvir lacking; extensive data available for ritonavir.	Lacks human pregnancy data; animal studies showed embryo toxicity and other risks.
Adverse Events in Pregnancy	Elevated liver enzymes (transaminitis), requiring monitoring.	Potential for drug-drug interactions, particularly with ritonavir.	Significant concerns regarding fetal risk based on animal studies.

Conclusion

While initial data on is remdesivir safe for pregnancy? was limited, accumulating evidence from real-world usage and dedicated studies is reassuring. Pharmacokinetic data show similar drug processing in pregnant and non-pregnant women, and observational studies suggest clinical benefits in treating moderate-to-severe COVID-19 during pregnancy without clear evidence of drug-related adverse fetal outcomes. The known risks of severe COVID-19 in pregnancy often outweigh the potential risks of remdesivir, but the decision should always be made in consultation with a healthcare provider who can weigh the individual's specific circumstances. Continued monitoring and further research will provide a more comprehensive picture, especially regarding first-trimester exposure and long-term outcomes.

This article does not replace professional medical advice. Always consult with a qualified healthcare provider for personalized recommendations regarding medication use during pregnancy. For additional information on medication use during pregnancy, visit MotherToBaby Fact Sheets.

Frequently Asked Questions

Historically, pregnant individuals have been excluded from many clinical trials due to ethical concerns about potential risks to the developing fetus, a practice criticized for leaving this population with limited evidence-based treatment options.

Studies in animal models indicate that while the parent drug, remdesivir, does not readily cross the placenta, its main metabolite, GS-441524, can and reaches the fetus. However, the significance of this transfer in humans is still being studied, and data from human use have not revealed related adverse fetal outcomes.

It is not known if remdesivir can affect fertility in men or women. Studies have not been conducted to evaluate this effect.

Data on remdesivir use during the first trimester, when organogenesis occurs, is very limited. Some authorities suggest using it only when clearly needed during this period, based on a careful risk-benefit analysis.

The most commonly reported adverse event associated with remdesivir is elevated liver enzymes (transaminitis). While often manageable, close monitoring is necessary, as severe elevation can lead to treatment discontinuation.

Remdesivir is administered intravenously and has more data supporting its use in moderate-to-severe COVID-19 in pregnancy. Paxlovid, an oral treatment, has limitations in pregnancy due to a lack of data on its component nirmatrelvir, though data for ritonavir are reassuring.

The main benefit is reducing the severity of COVID-19, which can decrease the length of hospital stays and the need for more intensive care. This is particularly important for pregnant patients who are at higher risk of severe disease.